Roche drug improves vision in diabetic eye disease

NEW YORK (Reuters) - Diabetic patients with a vision-robbing eye condition who were treated with Roche's Lucentis had significant and sustained vision improvement compared with those who received a placebo, according to data from a pair of pivotal clinical trials.

In addition, more than half of the patients with diabetic macular edema (DME) who received monthly Lucentis injections in the two-year studies improved to at least 20/40 vision, which would enable them to receive a driver's license in most U.S. states -- a result the lead investigator called "amazing."

"This is a real game changer. This can give you a rapid prolonged improvement of vision and it's sustained for at least two years," Dr. David Boyer, who presented the data on Tuesday at the American Diabetes Association (ADA) meeting in San Diego, said in a telephone interview.

"Within a week of treatment, Lucentis showed a reduction in thickness (of the edema) and improvement in vision," added Boyer, who practices at the Retina-Vitreous Associates Medical Group in Los Angeles.

DME is currently treated by laser, which stops blood vessel leakage and can slow vision loss but rarely leads to vision improvement, researchers said.

Roche's Genentech unit, which developed the drug, plans to apply for U.S. approval to treat the diabetic eye condition later this year, which could significantly boost sales.

Lucentis is already approved to treat wet age-related macular degeneration -- the leading cause of blindness among the elderly. DME is a leading cause of vision loss among people of working age.

Lucentis, a biotech drug known chemically as ranibizumab, met the primary goal of the two Phase III trials at both tested doses by helping significantly more patients achieve vision improvement of at least 15 letters, or three lines, on an eye chart than those who received sham injections.

In the 382-patient trial called Ride, 45.7 percent of those who received 0.5 milligrams of Lucentis and 33.6 percent who got 0.3mg Lucentis experienced vision improvement of at least 15 letters versus 12.3 percent in the placebo group.

In the 377-patient Rise trial, 39.2 percent who got the higher Lucentis dose and 44.8 percent who got the lower dose hit the primary vision improvement goal compared with 18.1 percent in the placebo group.

"This is a major paradigm shift. You're going to see over a period of time more and more people using this," Boyer said.

All patients in the two trials had vision problems related to their diabetes, researchers said.

DME is a swelling of the retina that occurs in diabetics who suffer from retinopathy - the most common diabetic eye disease that involves damaged blood vessels leaking fluid into the retina. It causes blurred vision and severe vision loss.

About 75,000 new cases of DME are estimated to develop among Americans each year, according to the ADA.

Lucentis patients in the studies were far less likely to see their disease progress to a more advanced form of retinopathy, the data showed.

Fifteen percent of those in the placebo group in one study and 11.5 percent in the other had significant disease progression. The rates for Lucentis were 5.6 percent and 3.9 percent at the higher 0.5mg dose and 1.6 percent and 3.2 percent at the 0.3mg dose.

As many as 63.2 percent on the higher Lucentis dose and 60 percent on the lower dose achieved vision of at least 20/40, compared with 37.8 percent and 34.6 percent on placebo.

"We got 60 percent of them now qualifying for drivers' licenses. These are major quality of life improvements," Boyer said.

He said Lucentis safety in the trials was consistent with what has been reported in previous studies, adding that "there was no real safety danger signals between the sham and the Lucentis groups."

Once approved for DME Lucentis will likely compete with a highly promising drug being developed by Regeneron Pharmaceuticals Inc and Roche's own cancer drug Avastin, which works in a similar manner as Lucentis.

Avastin, which is not approved for eye disease, costs a fraction of the Lucentis price when cut into the small doses needed for eye injection. It has been used extensively off label in place of Lucentis, hurting sales of the eye drug.

A recent U.S. government study found the two drugs to be similarly effective for macular degeneration treatment.

Anthony Adamis, global head of ophthalmology for Genentech, said Avastin increased the risk of stroke and heart attack in cancer trials and noted that diabetics are already at much higher risk for serious heart problems.

"My concern would be are you putting patients at increased risk (through off-label use of Avastin)? It's an open question," Adamis said.